Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
1993–2016 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 07, 2021
Single-use medical face mask
K201974 · FXX
Guangdong Horigen Mother & Baby...
General Hospital · 235d
Cleared Mar 05, 2021
Surgical Mask
K203425 · FXX
Bdc Dental Corporation , Ltd.
General Hospital · 105d
Cleared Mar 05, 2021
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
K202078 · LZA
Shen Wei (Usa), Inc.
General Hospital · 221d
Cleared Mar 05, 2021
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and...
K202076 · LZA
Shen Wei (Usa), Inc.
General Hospital · 221d
Cleared Mar 04, 2021
Surgical Face Mask
K210225 · FXX
Feng Chun Yuan Medical Equipment...
General Hospital · 35d
Cleared Mar 04, 2021
BD Intraosseous Infusion System
K203193 · MHC
Bard Access Systems,...
General Hospital · 127d
Cleared Mar 04, 2021
Disposable medical mask
K202137 · FXX
U-Play Products Corporation
General Hospital · 216d
Cleared Mar 03, 2021
3M Attest Rapid Readout Biological Indicator, 1295
K210277 · FRC
3M Company
General Hospital · 30d
Cleared Mar 03, 2021
EOGas 4 Endo-SteriTest RRBI
K202879 · FRC
Andersen Sterilizers, Inc.
General Hospital · 156d
Cleared Mar 03, 2021
Medical mask (Model: KKF-1A)
K202316 · FXX
Han Zhaoqing Sporting Goods Company...
General Hospital · 198d
Cleared Mar 02, 2021
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
K202356 · LZA
Kanglongda Vietnam Protection...
General Hospital · 195d
Cleared Mar 02, 2021
IFM Surgical Mask Model SM3
K202214 · FXX
Fssc, LLC
General Hospital · 208d
Cleared Mar 02, 2021
Surgical Mask-Model Number: Ear Loop, Flat-Pleated
K201852 · FXX
Huizhou Foryou Medical Devices Co., Ltd.
General Hospital · 239d
Cleared Mar 02, 2021
Arisure Closed System Drug Transfer Device (CSTD)
K201422 · ONB
Yukon Medical, LLC
General Hospital · 277d
Cleared Mar 01, 2021
Nitrile Examination Gloves (Blue, Violet Blue, White)
K202402 · LZA
Jiangsu Tianshuo Medical Products...
General Hospital · 192d
Cleared Mar 01, 2021
Getinge GSS610N Series Steam Sterilizer
K201927 · FLE
Maquet GmbH
General Hospital · 234d
Cleared Mar 01, 2021
Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
K201533 · KCT
Avinent Implant System S.L.U.
General Hospital · 266d
Cleared Feb 26, 2021
Disposable Vinyl Examination Gloves
K203439 · LYZ
Shandong Zhushi Pharmaceutical Group...
General Hospital · 95d
Cleared Feb 26, 2021
Medical infrared forehead thermometer
K202111 · FLL
Hunan Honggao Electronic Technolofy...
General Hospital · 211d
Cleared Feb 25, 2021
Surgical Masks
K203524 · FXX
Bain Medical Equipment (Guangzhou)...
General Hospital · 86d
Cleared Feb 25, 2021
Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
K203332 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 105d
Cleared Feb 25, 2021
Infrared Forehead Thermometer
K202420 · FLL
Conmo Electronic Company Limited
General Hospital · 185d
Cleared Feb 25, 2021
Disposable Surgical Mask/Fluid Resistant Procedure Mask
K202240 · FXX
Lhm Medical Technology (Hong Kong)...
General Hospital · 199d
Cleared Feb 25, 2021
KARL STORZ UDEL Sterilization Trays
K201945 · KCT
KARL STORZ Endoscopy-America, Inc.
General Hospital · 227d